An observational study in Heart Failure, sponsored by Bayer. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by Bayer · Observational
Researchers want to learn more about the treatments doctors choose to treat heart failure.
Heart failure means the heart isn't pumping as well as it should be. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.
There are different types of treatments available for people who have heart failure, and these work in different ways. In this study, the researchers will collect information about Colombian patients who have heart failure.
The main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in Columbia. To do this, the researchers will review information from the patients' medical records and from a drug-dispensing database.
The study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020.
There will be no required visits, treatments, or procedures in this study. The researchers will collect information about the treatments the patients have been prescribed by their own doctors.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 1,000 is above the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020.
The universe of the study corresponds to all individuals who are identified in the database as having HF diagnosed by ICD-10 code in the prescription; the target population corresponds to subjects who were diagnosed and prescribed with a HF treatment at the selected health insurance company and whose prescriptions were filled in Audifarma.
Exclusion Criteria:
Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020
Drug: HF medication
Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
Treatment initiation patterns
Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Dyspnea
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Fatigue
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Lower limb edema
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: EKG: main findings
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) or BNP (B-type natriuretic peptide)
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Serum Creatinine
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Subsequent treatment changes
Determination of subsequent treatment changes in HF outpatient.
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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